Adi Hoess, Affimed CEO (Affimed)

AACR: Ger­many's small NK cell play­er Af­fimed makes a big splash with ear­ly lym­phoma da­ta

Ger­man small-cap Af­fimed has long been high­light­ed as a po­ten­tial Cin­derel­la sto­ry, win­ning mile­stone-rich deals with Genen­tech and Roivant. And on Fri­day the biotech con­tin­ued its NK cell march, pre­sent­ing the first look at in-hu­man da­ta ahead of this week­end’s AACR con­fer­ence.

Re­searchers saw sig­nif­i­cant dis­ease re­duc­tion in all four lym­phoma pa­tients dosed with Af­fimed’s ex­per­i­men­tal off-the-shelf NK cell ther­a­py, with two reg­is­ter­ing com­plete re­spons­es as of the March 31 da­ta cut­off, the com­pa­ny an­nounced. All of the pa­tients had been heav­i­ly pre­treat­ed — with a range of four to 14 lines of pri­or ther­a­py — and there were no signs of cy­tokine re­lease syn­drome, tox­i­c­i­ty or graft-ver­sus-host dis­ease.

Three of the four pa­tients re­ceived the low­est dose, and en­roll­ment of the sec­ond dose co­hort is con­tin­u­ing in the MD An­der­son-spon­sored tri­al. All of the pa­tients had been di­ag­nosed with re­cur­rent/re­frac­to­ry CD30-pos­i­tive lym­phomas.

News of the da­ta sent Af­fimed $AFMD shares up about 23% when the mar­ket opened Fri­day morn­ing.

An­dreas Harstrick

The ther­a­py it­self con­tains what Af­fimed calls a bis­pe­cif­ic “in­nate cell en­gager” known as AFM13, and there are two steps to the treat­ment process for this pop­u­la­tion, CMO An­dreas Harstrick told End­points News. First, Af­fimed at­tach­es AFM13 to NK cells de­rived from healthy donors and ad­min­is­ters these to the pa­tients. Then, the pa­tients re­ceived three week­ly IV in­fu­sions of AFM13 by it­self.

These steps are nec­es­sary be­cause the pa­tients have weak­ened in­nate im­mune sys­tems and very low counts of NK cells, Harstrick said. If one were to give ei­ther NK cells or AFM13 by them­selves in this group of pa­tients, the re­sult would be a ther­a­py with “very lit­tle ef­fi­ca­cy” com­pared to com­bo, he said.

Af­fimed had to work through sev­er­al chal­lenges to get AFM13 to work as in­tend­ed, Harstrick added. Chief among those was de­vel­op­ing a way for the com­pound to tight­ly bind to both the NK cells and the CD30 tu­mor anti­gens, so that it wouldn’t be “washed off” when cir­cu­lat­ing the blood­stream.

The biotech solved that is­sue not on­ly through its tech that pro­vides tighter in­ter­ac­tions for the NK cell bind­ing site, but by prep­ping the NK cells with AFM13 in the first step of the treat­ment process, out­side the pa­tient. With Fri­day’s da­ta, Harstrick says it’s clear the NK cells are be­ing de­liv­ered to the right places.

“When you in­fuse these NK cells back to the pa­tient, all of these NK cells will car­ry AFM13 on their sur­face, and with the oth­er part of AFM13 we are bind­ing to CD30 on the tu­mor cells,” Harstrick told End­points. “So ba­si­cal­ly we train these NK cells to rec­og­nize the tu­mor with this very sim­ple method of co-cul­tur­ing and pre-in­cu­ba­tion.”

As the dose es­ca­lat­ing co­horts con­tin­ue, Af­fimed will in­crease the spe­cial­ly pre­pared NK cell count giv­en to the pa­tients. The week­ly AFM13 dos­es post-NK cell ad­min­is­tra­tion will re­main the same.

There are dif­fer­ent can­cers where AFM13 can po­ten­tial­ly be used on its own in pa­tients that have high­er NK cell counts, he added. One of these ar­eas is T cell lym­phomas, where Af­fimed is cur­rent­ly en­rolling a reg­is­tra­tional Phase II tri­al.

Some an­a­lysts looked fa­vor­ably on Fri­day’s news, with Jef­feries’ Mau­ry Ray­croft ap­pear­ing en­cour­aged. In a note to in­vestors ear­ly Fri­day morn­ing, Ray­croft wrote that even though the da­ta are ear­ly, they demon­strate the ther­a­py is ac­tive and sup­port the proof of con­cept.

Af­fimed ap­pears ready to prove its deal with Genen­tech back in 2018 will end up a big win­ner, when the biotech earned $96 mil­lion up­front and was promised up to $5 bil­lion in mile­stones to team up on its nat­ur­al killer cell plat­form for can­cer. Then last No­vem­ber, Af­fimed signed a li­cens­ing deal with Roivant for a dif­fer­ent pre­clin­i­cal pro­gram, AFM32.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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